Brand Name | 40" (102 CM) APPX 5.2 ML, ADMIN SET W/2 CHEMOLOCK¿ |
Type of Device | CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM |
Manufacturer (Section D) |
ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. |
avenida cuarzo no. 250 |
ensenada, b.cfa. 22790 |
MX 22790 |
|
Manufacturer Contact |
patricia
sharpe-gregg, bsn, rn
|
600 n. field dr. |
lake forest 60045
|
2247062300
|
|
MDR Report Key | 8190601 |
MDR Text Key | 131496528 |
Report Number | 9617594-2018-00230 |
Device Sequence Number | 1 |
Product Code |
ONB
|
UDI-Device Identifier | 00887709057036 |
UDI-Public | (01)00887709057036(17)231001(10)3793043 |
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K131549 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
11/30/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 10/01/2023 |
Device Model Number | CL3520 |
Device Catalogue Number | CL3520 |
Device Lot Number | 3793043 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/30/2018 |
Initial Date FDA Received | 12/21/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/01/2018 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |